Trade Names:Ortho Evra- Patch, transdermal norelgestromin 6 mg/ethinyl estradiol 0.75 mg
Inhibits ovulation by suppressing gonadotropins; alters cervical mucus, which increases the difficulty of sperm entry into the uterus; and alters the endometrium, which reduces the likelihood of implantation.
Prevention of pregnancy.
Thrombophlebitis; thromboembolic disorders; history of deep vein thrombophlebitis; cerebral vascular disease; coronary artery disease; valvular heart disease with complications; severe hypertension; diabetes with vascular involvement; headaches with focal neurological symptoms; major surgery with prolonged immobilization; known or suspected carcinoma of the breast; carcinoma of the endometrium; estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; cholestatic jaundice of pregnancy; jaundice with prior hormonal contraceptive use; acute or chronic hepatocellular disease with abnormal liver function; hepatic adenomas or carcinomas; pregnancy; hypersensitivity to any component of the product.
Transdermal Apply 1 patch each week for 3 weeks (21 days). Apply every new patch on the same day of each week (patch change day). Week 4 is patch-free and withdrawal bleeding is expected at this time. On the day after week 4 ends, a new 4-wk cycle is started by applying a new patch.
Store at 59° to 86°F. Store patches in their protective pouches. Apply immediately upon removal from the protective pouch. Do not store in the refrigerator or freezer.
Ethinyl estradiol concentrations may be elevated, increasing the risk of adverse reactions.Acetaminophen, clofibric acid, lamotrigine, morphine, salicylic acid, temazepam, valproic acid
Plasma concentrations of these agents may be reduced, decreasing their effectiveness.Antibiotics (eg, tetracycline), barbiturates (eg, phenobarbital, primidone), bosentan, carbamazepine, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, rifampin, St. John's wort, topiramate
Hormonal contraceptive effectiveness may be decreased. Use an additional nonhormonal form of birth control during concomitant therapy.Benzodiazepines, beta-blockers (eg, metoprolol, propranolol), caffeine, corticosteroids (eg, prednisolone), cyclosporine, selegiline, theophylline, tricyclic antidepressants
Plasma concentrations of these agents may be elevated, increasing the risk of adverse reactions.Protease inhibitors (eg, ritonavir)
Increase or decrease in the plasma levels of estrogens and progestins has been noted.
Prothrombin and factors VII, VIII, IX, and X; norepinephrine-induced platelet aggregability; thyroid-binding globulin leading to increased circulating total thyroid hormone as measured by protein-bound iodine; T4 by column or by radioimmunoassay; other binding proteins; sex hormone–binding globulins, which results in elevated levels of total circulating endogenous sex steroids and corticoids (however, free or biologically active levels either decrease or remain unchanged); triglycerides and other lipids and lipoproteins.Decreased
Antithrombin III; free T3 resin uptake; glucose tolerance; serum folate levels.
Headache (9% to 22%); cerebral hemorrhage, cerebral thrombosis.
Abdominal pain, nausea (9% to 22%); mesenteric thrombosis.
Breast symptoms, menstrual cramps (9% to 22%).
Arterial thromboembolism, thrombophlebitis, venous thrombosis.
Benign liver tumors, gallbladder disease, hepatic adenomas.
Application-site reaction (9% to 22%).
Upper respiratory tract infection (9% to 22%); pulmonary embolism.
Cigarette smoking increases the risk of serious CV adverse reactions. The risk increases with age (older than 35 yr of age) and smoking at least 15 cigarettes/day. Women using hormonal contraceptives should not smoke.
Monitor blood glucose in women with diabetes. Perform routine annual medical evaluation, including physical examination and relevant laboratory tests. Closely monitor women being treated for hyperlipidemia. Carefully monitor women with conditions that may be aggravated by fluid retention.
Category X .
Undetermined; however, contraceptive steroids are excreted in breast milk.
Safety and efficacy are expected to be the same for postpubertal adolescents younger than 16 yr of age and for patients 16 yr of age and older. Use before menarche is not indicated.
Not indicated in elderly patients.
Estrogens may be poorly metabolized in patients with impaired liver function. Discontinue use if jaundice develops.
Breakthrough bleeding and spotting may occur.
Encourage women with hypertension or hypertension-related diseases to use another nonhormonal method of contraception.
Clinical trials suggest that norelgestromin/ethinyl estradiol transdermal may be less effective in women weighing 90 kg (198 lb) or more than in lower-weight women.
Glucose tolerance may be decreased. Changes in serum triglycerides and lipoprotein levels have been reported. Some progestins may elevate LDL levels and interfere with control of hyperlipidemia.
Risk of breast cancer may be slightly increased but decreases over time after oral contraception discontinuation, and the increased risk disappears by 10 yr after cessation of use.
Increased risk of MI has been attributed to hormonal contraceptive use, primarily in smokers or women with underlying risk factors for coronary artery disease (eg, diabetes, hypertension, obesity). Increased risk of thrombotic disease associated with hormonal contraceptive use is well established. Use with caution in women with CV disease risk factors (eg, hyperlipidemia).
Increase in the relative and attributable risk of cerebrovascular events (eg, thrombotic and hemorrhagic strokes) has been reported. The risk is greatest among hypertensive women who are older than 35 yr of age and who smoke.
Use with caution in women with a history of depression.
Ectopic or intrauterine pregnancy may occur in contraceptive failure.
May occur. Use with caution in women with conditions that may be aggravated by fluid retention.
Existing gallbladder disease may be worsened or development of this condition may be accelerated in previously asymptomatic women.
Discontinue the contraceptive patch if there is exacerbation of migraine or development of headache with a new pattern that is recurrent, persistent, or severe.
Benign hepatic adenomas, which may cause death through intra-abdominal hemorrhage, have been associated with hormonal contraceptive use.
The pharmacokinetic profile for the contraceptive patch is different from that of oral contraceptives in that it has higher steady-state concentrations and lower peak concentrations. Increased estrogen exposure may increase the risk of adverse reactions, including venous thromboembolism.
Discontinue during and following prolonged immobilization.
Discontinue at least 4 wk prior and for 2 wk after elective surgery associated with an increase in risk of thromboembolism.
A positive association has been seen between amount of estrogen and progestin in hormonal contraceptives and risk of vascular disease. Many progestational agents have been reported to decrease HDL, which is associated with an increased incidence of ischemic heart disease.
Retinal vascular thrombosis may occur, leading to loss of vision, sudden onset of proptosis, diplopia, or migraine.
Nausea, menstrual irregularities, vaginal bleeding, vomiting.
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